CRANIAL-MAXILLOFACIAL IMPLANT

Abstract

Provided herein is an implant made of a biocompatible ceramic of synthetic origin obtained by additive manufacturing. The implant may include a dense portion featuring a material density by volume greater than 70%, and a porous portion connected to the dense portion by a connection zone. The porous portion may have an average macroporosity having a material density ranging from 30% to 70% by volume and cavities defining cavity sections, with a diameter ranging from 0.3 mm to 1.2 mm. The dense portion and the porous portion may define an external surface. The cavities may open onto the external surface.

Claims

1. An implant made of a biocompatible ceramic of synthetic origin obtained by additive manufacturing and comprising: a dense portion, with a material density by volume greater than 70%, and a porous portion connected to said dense portion by a connection zone, said porous portion comprising an average macroporosity characterized by: an average material density determined for the entire volume of said porous portion of between 30% and 70% by volume; cavities delimited at least partially by side walls defining cavity sections, said cavity sections each having an extension such that it is possible to fit each of said cavity sections in a circle having a diameter ranging from 0.3 mm to 1.2 mm; said dense portion and said porous portion define at least partially an external surface of the implant; said cavities open onto said external surface.

2.-3. (canceled)

4. The implant according to claim 1, wherein the side walls delimiting at least partially the cavities are defined by a triply periodic minimal surface.

5. The implant according to claim 1, wherein said side walls are smooth.

6. (canceled)

7. The implant according to claim 1, wherein said side walls comprise a single non-intersecting surface.

8. (canceled)

9. The implant according to claim 1, wherein the porous portion has a gradient of material density by volume between the connection zone and said external surface such that the material density of the porous portion is greater at the level of the connection zone than it is at the level of the external surface.

10. (canceled)

11. The implant according to claim 1, wherein said cavities of said porous portion are interconnected.

12. (canceled)

13. The implant according to claim 1, wherein said diameters of the cavities are distributed according to a gradient substantially defined between said connection zone and said openings of the porous portion.

14. (canceled)

15. The implant according to claim 1, wherein the implant is a cranial-maxillofacial implant.

16. The implant according to claim 1, wherein the cavities are closed at the level of said connection zone.

17.-18. (canceled)

19. The implant according to claim 1, wherein said dense portion is defined by a repetition of a second basic pattern.

20. The implant according to the claim 19, wherein the second basic pattern is of the gyroid type.

21. The implant according to claim 1, further comprising at least an attachment hole performed through said dense portion and/or said porous portion.

22. The implant according to claim 1, further comprising at least two dense portions, said implant comprising at least two attachment holes traversing said at least two dense portions.

23. The implant according to claim 1, further comprising: an intermediate portion connected to said dense portion and to said porous portion, and featuring an average macroporosity characterized by: an average material density determined for the entire volume of said intermediate portion of between 50% and 90% by volume; cavities delimited at least partially by side walls defining cavity sections, said cavity sections each having an extension such that it is possible to fit each of said cavity sections of the intermediate portion in a circle having a diameter ranging from 0.2 mm to 0.7 mm; said dense portion, said intermediate portion, and said porous portion define at least partially an external surface of the implant; said cavities open onto said external surface.

24.-37. (canceled)

38. The implant according to claim 1, wherein the diameters of the cavities are distributed periodically within the implant.

39. The implant according to claim 1, wherein said cavities of said porous portion are arranged according to a meshing of the cavities enabling substantially all of the cavities to communicate with one another.

40. The implant according to claim 1, wherein the cavities all communicate with said external surface.

41.-45. (canceled)

46. The implant according to claim 1, said cavities of said porous portion are substantially parallel with one another.

47. (canceled)

48. A method for manufacturing the implant according to claim 1 according to and comprising the following steps: a. defining a design space of the implant, said design space being defined by a space that requires filling by the implant; b. defining, for said implant, the following design parameters: the required mechanical properties of the implant; the positions of the external surfaces of the implant; a characteristic of the tissues and/or materials delimiting the design space of the implant; c. defining an implant that substantially fits with the design space, said implant comprising at least one dense portion, and at least one porous portion; d. optimizing a shape of said implant within said design space by using a topology optimization method taking into account said design parameters of said implant, so as to achieve an optimized shape of said implant; e. providing an additive manufacturing machine; f. providing a program for the breakdown into slices defining a number M of layers and the geometry of the layers that are to be deposited for the additive manufacturing of said implant, M being a positive integer equal to or greater than 2; g. providing a material to be deposited that comprises synthetic bioceramic; h. depositing a layer of said material to be deposited on a support; i. solidifying said layer; j. repeating said steps h. and i. M-1 times, such as defined by said breakdown program; k. removing said material to be deposited that has not been solidified; l. conducting a heat treatment of said printed layers in order to consolidate the remaining fraction.

49. A manufacturing method according to claim 19, further comprising: defining the location of at least one attachment means based on the nature of the tissue and/or materials delimiting the design space of the implant.

50.-54. (canceled)

Description

BRIEF DESCRIPTION OF THE FIGURES

[0183] These aspects, as well as other aspects of the invention, are clarified in the following detailed description of specific embodiments of the invention, with reference to the drawings of the figures, in which:

[0184] FIGS. 1a to 1c show schematic cross-section views of several embodiments of an implant according to the invention;

[0185] FIGS. 2a to 2c show schematic cross-section views of several embodiments of an implant according to the invention;

[0186] FIGS. 3a to 3c show schematic cross-section views of several embodiments of an implant according to the invention;

[0187] FIGS. 4a to 4c show schematic views of several embodiments of an implant according to the invention comprising attachment holes;

[0188] FIGS. 5a and 5b show schematic views of an embodiment of an implant according to the invention;

[0189] FIGS. 6a and 6b show views of a basic pattern; FIG. 6c shows a schematic view of a portion of an implant comprising 8 basic patterns;

[0190] FIG. 7a shows a basic pattern and FIG. 7b shows an assembly of several basic patterns according to FIG. 7a.

[0191] The drawings of the figures are not to scale. Generally, similar elements are designated by similar references in the figures. The presence of reference numbers in the drawings cannot be considered as being limiting, including when these numbers are provided in the claims.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS OF THE INVENTION

[0192] FIG. 1a shows an example of an embodiment of an implant 10 comprising a dense portion 1 and a porous portion 3 delimited by a connection zone 2. The implant 10 has an external surface 8 that delimits the dense 1 and porous 3 portions from the exterior. The porous portion 3 comprises cavities 5 defining the macroporosity of the implant 10. These cavities 5 are schematically represented by parallel hollow sections and, when in the same plane, should be considered as a set of cavities in a three-dimensional space. The cavities 5 also comprise interconnections under the surface 8, so as to form a meshing of cavities. The cavities 5 communicate with the external surface 8 through openings 6. FIG. 1a can be seen as an example of a cross-section view of an implant 10 according to the invention, not showing the interconnection between the cavities 5, although such an interconnection exists.

[0193] FIG. 1b shows a different version of FIG. 1a where the dense portion 1 is central in the implant 10 and where the porous portion 3 is peripheral to the implant 10. The dense portion 1 therefore plays the role of a skeleton to provide the implant with good mechanical properties, and the peripheral porous portion enables good osseointegration during the implantation thereof. The porous portion 3 located in the periphery of the dense portion 1 can comprise several porous portions 3, for example there exists under the external surface 8 of the implant 10 an alternation of dense parts of the dense portion 1 and an alternation of porous portions 3.

[0194] FIG. 1c shows another version of FIGS. 1a and 1b. The porous portion 3 in contact with the dense portion 1 at the level of the connection zone 2 defines a height of the porous portion that can be varied and fits with the surface of the dense portion 1. FIG. 1c shows an example of an implant for which, under the external surface 8, there exist zones of dense portion 1 and of porous portion 3. Furthermore, the porous portion 3 can have different heights depending on its location and possibly based on the bony part with which the implant is to be in contact. Furthermore, the walls of the cavities of the porous part can have different thicknesses based on various requirements in terms of osseointegration speed or of bioresorbtion speed.

[0195] FIG. 2a shows an example of an embodiment of an implant 10 such as described in FIG. 1a and for which the material density of the porous portion 3 is distributed so that the material density is greater at the level or at the point of contact of the connection zone 2 than at the level of the external surface 8 of the porous portion 3. The distribution of the material density is schematically shown by the cavities 5 such as represented, with cavity diameters at the level of their communication 6 with the external surface 8 that are greater than the cavity diameters at the level of the connection zone 2. This implies, among other aspects, that the thickness of the walls of the cavities is greater at the level of the connection zone 2 than at the level directly underneath the surface 8. Based on this schematic representation, the implant can therefore feature very different external aspects, as is shown in FIGS. 2b and 2c.

[0196] FIG. 2b shows an example of an implant such as described in FIG. 1b and comprising the material density distribution properties in the porous portion 3 with respect to the dense portion 1 such as described for FIG. 2a.

[0197] FIG. 2c shows an example of an implant such as described in FIG. 1c and comprising the material density distribution properties in the porous portion 3 with respect to the dense portion 1 such as described for FIG. 2a.

[0198] FIG. 3a shows an example of an implant 10 such as described in FIG. 2a, for which the porous portion 3 located under a large part of the external surface 8 delimiting the porous portion 3, i.e. over a thickness of 1 to 5 mm, has a material density ranging from 30% to 40%. The porous portion 3 located directly in contact with the dense portion 1 at the level of the connection zone has a material density ranging from 70% to 100%. The material density of the porous portion is always strictly inferior to 100%. The distribution of the material density between the two ends of the porous portion 3 can be linear, i.e. the material density distribution varies linearly with its position throughout the thickness of the porous portion 3. The distribution of the material density in the porous portion 3 can also be logarithmic, i.e. the distribution varies quickly in the vicinity of the external surface, and more slowly in the vicinity of the connection zone. The dense portion 1 has a material density equal to 100%, or in any case tending towards 100%. A dense portion in which the material density is of less than 100% may be considered if the manufacturing process does not achieve a material density of 100%. A dense portion 1 in which the material density is slightly less than 100% would not have a macroporosity such as that of the porous portion 3. A dense portion 1 in which the material density is slightly less than 100% would possibly have a closed porosity, contrary to the porosity of the porous portion 3, which is open.

[0199] FIG. 3b shows an example of an implant such as described in FIG. 2b and comprising the material density distribution properties in the porous portion 3 with respect to the dense portion 1 such as described for FIG. 3a.

[0200] FIG. 3c shows an example of an implant such as described in FIG. 2c and comprising the material density distribution properties in the porous portion 3 with respect to the dense portion 1 such as described for FIG. 3a.

[0201] In FIGS. 1a to 3c, the external surface 8 covering the porous portion 3 is continuous, i.e. it comprises a surface in which the openings 6 of the cavities 5 create holes.

[0202] FIG. 4a shows an embodiment example of the implant according to any one of the embodiments listed in the description of FIGS. 1a to 3c. The implant shown in FIG. 4a displays a porous portion 3 attached to the dense portion 1. The porous portion 3 has cavities 5 that open onto the external surface 8 by openings 6. The dense portion 1 features an attachment hole 9 to attach the implant 10 to a bone or to another part of the body on which the implant is intended to be implanted. Preferably, the implant 10 is mechanically coupled to a bone by an attachment means such as a screw that is screwed through the attachment hole 9. The screw has a screw diameter that is equal or inferior to the diameter of the attachment hole 9, and the screw head has a diameter that is greater than the diameter of the attachment hole 9. The location of the openings 6 of the cavities 5 is provided purely by way of example. The implant can have several attachment holes 9, for example two attachment holes 9 being positioned on either side of an implant with a substantially longitudinal shape. The attachment hole can, for example, include a location for the screw head that is recessed in the implant so that when the screw is in place to support the implant, the screw head is substantially below the external surface 8. For example, the attachment hole 9 features a geometry specific to a screw head, in particular to ensure that the forces applied by the screw during its tightening on the implant are correctly distributed throughout the implant. A large contact area between the screw head and the implant 10 is preferred.

[0203] FIG. 4b shows an example of an implant such as defined in FIG. 4a and comprising a porous portion 3 surrounding the attachment hole 9. For example, the porous portion is located at the level of a single face of the implant 10 featuring an opening of the attachment hole 9.

[0204] FIG. 4c shows an example of an implant such as described in FIGS. 4b and 4a and comprising a porous portion 3 on the entire periphery of the implant, the dense portion being represented as a dotted line is located under the porous portion 3 and ensures that the implant 10 features sufficient mechanical properties.

[0205] The implant 10 is preferably made by 3D printing with a material featuring a very high particle concentration of materials enriched in hydroxyapatite and tricalcium phosphate. The implant 10 preferably undergoes chemical and thermal treatments to remove all organic components. Preferably, the particles of materials enriched in phosphate and calcium are sintered to obtain an implant 10 made of ceramic material.

[0206] The bioglass that can be used in the implant 10 has for example a composition by weight with 45% silicon oxide, 24.5% sodium oxide, 24.5% calcium oxide and 6% of phosphorous oxide.

[0207] The implant 10 is for example manufactured by machining operations performed on a block. The implant 10 is for example shaped by a method of injection moulding.

[0208] The implant 10 can be manufactured in different dimensions depending on the required shape of the implant and its osseointegration, bioabsorption and mechanical properties. The implant 10 can be adapted to male and female patients of all sizes, in order to fill or reconstruct any type of bone.

[0209] The implant 10 is preferably attached. The implant 10 is for example attached with screws or with glue to a bone of the person who receives the implant 10. The implant 10 is, for example, attached to cartilage. The implant 10 can be attached to a bone and/or to cartilage. Any other combination enabling the attachment of the implant 10 is possible.

[0210] The implant 10 has a material density by volume preferably ranging from 20% to 100%, and more preferably from 50% to 80%. For example, a density of 100% corresponds to an implant 10 without porosity, i.e. entirely made of ceramic material. For example, an implant 10 with a porosity of 60% by volume is made of, in terms of volume, 60% of ceramic material and of 40% of absence of ceramic material. The absence of ceramic material corresponds to the macroporosity of the implant 10.

[0211] Interconnected macroporosity is preferably present in the porous portion 3. For example, the dense portion 1 requires mechanical properties ensuring the implant is properly supported as it undergoes constraints of everyday life, and the porous portion 3 enables proper osseointegration and/or good bioresorbtion so that the implant becomes secured to the bone. Preferably, the implant features a good ratio of the dense portion 1 to the porous portion 3 so that osseointegration of the porous portion is quick and enables a proper connection of the dense portion to the bone on which it is implanted, so that the dense portion has mechanical properties that are similar to, and even better than that of the original bone. The dense portion, depending on its dimensions, will undergo varying bioresorbtion/biointegration speeds.

[0212] Preferably, the thickness of the porous portion 3 varies from 0.5 mm to 10 mm. Preferably, the porous portion 3 is thinner at its ends and thicker in its centre, as shown in FIGS. 1c, 2c and 3c.

[0213] FIG. 5a shows an implant 10 comprising four dense portions 1, and an intermediate portion 4 mechanically coupling the four dense portions 1. The intermediate portion 4 is mechanically coupled to a porous portion 3. This embodiment combines good bioresorbtion properties with good mechanical properties. The transfer of constraints occurs preferentially from the dense portions 1 towards the porous portion 3, passing through the intermediate portion 4. The dense portions 1 comprise attachment holes 9 or holes intended for the fixing of the implant 10. FIG. 5b shows a cross-section view along the axis A-A of FIG. 5a. The porous portions 3 preferably comprise a portion of the porous portion that is peripheral to the implant and that has a thickness that is thinner than the thickness of the porous portion 3 in contact with the intermediate portion 4, so as to provide improved short-term biointegration properties.

[0214] FIGS. 6a and 6b show a same basic pattern of the gyroid type, under different viewing angles, i.e. defining a triply periodic minimal surface (more broadly than gyroid). For example, the basic pattern of FIGS. 6a to 6c is defined, in a three-dimensional space (x, y, z) with the equation cos x.Math.sin y+cos y.Math.sin z+cos z.Math.sin x=0, which provides a non-minimal surface that nonetheless has a result that is very close to that of an actual gyroid. FIG. 6c shows a set of eight basic patterns such as that shown in FIGS. 6a and 6b. Thus, the creation of a network of basic patterns make it possible to achieve a porosity comprising cavities with well-controlled sections, without changing the dimensions of the cavity sections at the level of the connections between the basic patterns and the walls of the cavities (or side walls 50) and without an abrupt change of the orientation of the cavity walls. The side walls 50 that do not feature an abrupt change of their orientation are said to be non-self-intersecting. Such a network of basic patterns enables the creation of a network of cavities, all interconnected with one another. The advantage of such a network of basic patterns is that it changes the volume density of a portion of the implant 10 comprising such a network of basic patterns, for example by changing the thickness of the cavity walls for a same dimension of the basic pattern. Another advantage of having such a network of basic patterns for the creation of the implant is that it changes the number of cavities per unit of volume, by varying the dimensions of the implant, while retaining the volume density of the portion of the implant 10. Preferably, a portion of the implant formed by the network of basic patterns according to the invention comprises cavity walls 50, 42, 12.

[0215] FIGS. 7a and 7b show in FIG. 7a a basic pattern intended to form a portion of the implant such as shown in FIG. 7b. FIG. 7a shows a basic pattern comprising a hollow sphere with six orifices enabling the creation of a network of basic patterns according to FIG. 7b in a three-dimensional space. An advantage of this basic pattern and of the network is that it creates a double network of cavities, each cavity network featuring three-dimensional interconnections.

[0216] A method for manufacturing the implant 10 using a 3D printing technique enables the manufacturing of an implant 10 from a printing material. This embodiment of the invention relies on the availability of a 3D printer depositing the printing material in a controlled manner. The 3D printer, for example, deposits thin uniform layers of the printing material. Furthermore, the 3D printing machine has a light source in which the wavelength enables the light curing of the material to be printed as well as an optical projection system exposing the printing material during its deposition. The printing material, when exposed to the light source, is cured thanks to the presence of photoinitiators and monomers or polymers able to react with the photoinitiators present in the composition of the printing material.

[0217] The light curing of a first layer of the printing material deposits on it a second layer of printing material. The successive curing of the deposited layers, following a well-defined geometry for each one of the layers, enables the manufacturing of the implant 10 according to the invention.

[0218] The geometry of the printed layers is defined by a program that breaks the object down into slices. This program, for example, defines the thickness of the printed slices. A breakdown into slices of reduced thickness provides a better level of detail of the finished product. A breakdown into slices of increased thickness provides a reduced level of detail of the finished product. The number of slices the facial implant is broken down into is selected based on the manufacturing time and the required level of detail, in particular. Thicker slices require a longer exposure of the layer to the source of light or exposure to a source of light that delivers increased light intensity.

[0219] The printing material is, preferably, a formulation highly enriched in inorganic materials in the form of particles. The particles are preferably enriched in hydroxyapatite and tricalcium phosphate. The light-curing polymer-based material and the photoinitiator bonds the particles of inorganic materials in order to achieve a printing material with no inclusion of air. The printing material preferably has a relatively high viscosity, preferably ranging from 0.01 Pa.Math.s to 1000 Pa.Math.s to ensure that it remains in place before and during the light-curing step.

[0220] After the printing and curing of the different layers, any non-cured printing material is removed from the printed item. This step is for example conducted by immersing the printed item in a solvent bath. This step can further be completed by a thermal treatment.

[0221] After the printing and curing of the various layers, the ceramic particles are preferably compacted with one another.

[0222] The manufacturing of the implant 10 by an additive manufacturing method can be conducted by stereolithography.

[0223] The manufacturing of the implant 10 by an additive manufacturing method can be conducted by binder jetting, i.e. the deposition of successive layers of a binder on a powder bed. The powder bed is made of particles of synthetic bioceramic for example.

[0224] For example, an additive manufacturing method of ceramic integrates materials, manufacturing machines and designs such that: [0225] The machine virtually divides the 3D file into a succession of very thin layers. [0226] The printer then spreads a material layer (25 to 100 μm) and a UV source (DLP) is simultaneously activated to harden the material. [0227] The machine then spreads a new layer on top of the first one, hardens the material, and repeats this step until the object is fully manufactured. [0228] At the end of the process, the object is retrieved and excess material is removed. [0229] To obtain objects made purely of ceramic, the resin has to be eliminated and the powder must be compacted. The parts are placed in an oven to burn off the resin (debinding step). The grains of ceramic are bonded to one another by very weak chemical bonds. [0230] The temperature increase merges the grains of powder at the level of the grain surfaces (sintering step). [0231] Once removed from the oven, the parts are inspected and their dimensions are checked.

[0232] The present invention has been described for specific embodiments, that are provided solely by way of example and cannot be considered as being limited thereto. Generally speaking, the present invention is not limited to the examples provided and/or described above. The use of terms such as “comprise”, “include”, “feature” or any other variant thereof, and their conjugated forms, are not to be taken to exclude the presence of elements other than those mentioned. The use of an indefinite article “a” or of the definite article “the” to introduce an element does not exclude the presence of a plurality of these elements. The reference numbers in the claims do not limit the scope thereof.

[0233] In short, the invention can also be described as follows.

[0234] Implant 10 made of a biocompatible ceramic of synthetic origin obtained by additive manufacturing and comprising: [0235] a dense portion 1 featuring a material density by volume greater than 70%, and [0236] a porous portion 3 connected to said dense portion 1 by a connection zone 2, said porous portion 3 comprising an average macroporosity characterised by: [0237] a material density ranging from 30% to 70% by volume; [0238] cavities 5 defining cavity sections, with a diameter ranging from 0.3 mm to 1.2 mm;
said dense portion 1 and said porous portion 3 defining an external surface 8;
said cavities 5 open onto said external surface 8.